Process for making pre-formed objects

ABSTRACT

Disclosed is a continuous line process for making a pre-formed object having a plurality of surfaces comprising the steps of:  
     (1) providing a sol phase of the composition comprising a solvent and a gelling agent having a sol-gel transition point between about the melting point of the solvent and about the boiling point of the solvent;  
     (2) forming surfaces of the sol phase composition by passing through a surface forming system, the surface forming system pressing the sol phase composition between a plurality of liners;  
     (3) cooling the sol phase composition into a gel phase; and  
     (4) cutting the gel phase composition;  
     wherein the pre-formed object is free of a supporting substrate.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S.Provisional Application Serial No. 60/339,287, filed Dec. 11, 2001,which is herein incorporated by reference.

FIELD

[0002] The present invention relates to a continuous line process formaking a pre-formed object, which is free of a supporting substrate,made of a composition comprising a solvent and a gelling agent having asol-gel transition point between about the melting point of the solventand about the boiling point of the solvent. The process is suitable forproviding stable pre-formed objects in large scale manufacturing.

BACKGROUND

[0003] Pre-formed objects made of gelling agents, which are free ofsupporting substrates, provide unique benefits to various consumerproducts due to its formed, yet flexible physical characteristics.Pre-formed patch and mask devices are useful for cosmetic anddermatological treatment products such as for delivering skin careactives, percutaneously deliverable pharmaceuticals, and for promotinghealing of burns or wounds. Edible pre-formed sheets and objects providenutritional products and snacks having distinctive appearance and oraltexture, and oral administrative pharmaceuticals.

[0004] Co-pending PCT application US/00/09694 relates to a pre-formedcosmetic device for delivering skin benefit agents to the skin, hair ornails, the cosmetic device comprising a solid gel sheet having opposedfirst and second surfaces, wherein the gel sheet comprises one or moregelling agents and topical acceptable hydrophilic solvent. In PCTapplication US/00/09694, injection molding is disclosed as a preferredembodiment for producing the gel sheet.

[0005] While injection molding is one effective method to providepre-formed objects, particularly in small scale production, such methodis not desirable for producing large quantities of pre-formed objectsdue to the complexity of instruments required to form the composition atcontrolled temperatures and speed. Further, in that forming ofcompositions containing gelling agents by injection molding requireflash cooling of the composition, this may result in compositions thatdo not have a stable rheology. Unstable rheology of a pre-formed objecthaving no supporting substrate may lead to unstableness of the form ofthe product, leaking of the product from the packaging, or ineffectivedelivery of actives via the product. All of such may significantlyaffect product performance and/or aesthetics.

[0006] Based on the foregoing, there is a need for a process forproducing a stable pre-formed object which is free of a supportingsubstrate, that can be applied to large scale manufacturing.

[0007] None of the existing art provides all of the advantages andbenefits of the present invention.

SUMMARY

[0008] The present invention is directed to a continuous line processfor making a pre-formed object having a plurality of surfaces comprisingthe steps of:

[0009] (1) providing a sol phase of the composition comprising a solventand a gelling agent having a sol-gel transition point between about themelting point of the solvent and about the boiling point of the solvent;

[0010] (2) forming surfaces of the sol phase composition by passingthrough a surface forming system, the surface forming system pressingthe sol phase composition between a plurality of liners;

[0011] (3) cooling the sol phase composition into a gel phase; and

[0012] (4) cutting the gel phase composition;

[0013] wherein the pre-formed object is free of a supporting substrate.

[0014] The process provides a process, particularly suitable for largescale manufacturing, for producing a stable pre-formed object which isfree of a supporting substrate.

[0015] The present invention is further directed to a pre-formed objectmade by the process above.

[0016] The present invention is further directed to a use of thepre-formed object made by the process above as a cosmetic product, apharmaceutical product, or a food product.

[0017] The present invention is further directed to a cosmetic devicecomprising the pre-formed object made by the process above and a coatingcomposition.

[0018] The present invention is further directed to a cosmetic devicecomprising a pre-formed sheet having a first surface having a specifiedtexture, and a coating composition of a specified viscosity.

[0019] These and other features, aspects, and advantages of the presentinvention will become better understood from a reading of the followingdescription, and appended claims.

BRIEF DESCRIPTION OF THE FIGURES

[0020] While the specification concludes with claims particularlypointing out and distinctly claiming the invention, it is believed thatthe present invention will be better understood from the followingdescription of preferred, nonlimiting embodiments and representationstaken in conjunction with the accompanying drawings in which:

[0021]FIG. 1 is a schematic view of a preferred embodiment of theprocess of the present invention.

[0022]FIG. 2 is another schematic view of a preferred embodiment of theprocess of the present invention.

[0023]FIG. 3 is a schematic view of a preferred embodiment of thesurface forming system of the present invention.

[0024]FIG. 4 is a schematic view of a preferred embodiment of thecutting system of the present invention.

[0025]FIG. 5 is a perspective view of a preferred embodiment of thepre-formed sheet of the present invention.

[0026]FIG. 6 is an enlarged, partially segmented perspective view of thefirst surface vicinity of a preferred embodiment of the pre-formed sheetof the present invention.

[0027]FIG. 7 is a sectional view of a preferred embodiment of thecosmetic device of the present invention.

[0028]FIG. 8 is a schematic view of a set up for measuring flex angle.

DEFINITIONS

[0029] All cited references are incorporated herein by reference intheir entireties. Citation of any reference is not an admissionregarding any determination as to its availability as prior art to theclaimed invention.

[0030] Herein, “comprising” means that other steps and other ingredientswhich do not affect the end result can be added. This term encompassesthe terms “consisting of” and “consisting essentially of”.

[0031] All percentages, parts and ratios are based upon the total weightof the compositions of the present invention, unless otherwisespecified. All such weights as they pertain to listed ingredients arebased on the active level and, therefore, do not include carriers orby-products that may be included in commercially available materials.All measurements are conducted at 25° C. unless otherwise specified.

[0032] All ingredients such as actives and other ingredients usefulherein may be categorized or described by their cosmetic and/ortherapeutic benefit or their postulated mode of action. However, it isto be understood that the active and other ingredients useful hereincan, in some instances, provide more than one cosmetic and/ortherapeutic benefit or operate via more than one mode of action.Therefore, classifications herein are made for the sake of convenienceand are not intended to limit an ingredient to the particularly statedapplication or applications listed.

[0033] The term “pre-formed” as used herein, means that the object ismanufactured into a form having a predetermined shape and size, whereinthe object may be removed from any associated packaging and placed ordraped onto the target surface by the fingers without furtherpreparative steps by the user. The term “pre-formed” also means that,when manufacturing is completed, the object substantially retains itsshape at the desired normal storage temperature when lying on a flatsurface. The composition may nevertheless flex or be deformed whenapplied to an uneven surface or if impressed.

[0034] The term “free of supporting substrate” as used herein, means thepre-formed object is uniform and unilamellar in composition, with noadditional substrate or layer for aiding in the structure or integrityof the pre-formed object.

[0035] The term “sol phase composition” as used herein, means thecomposition for making the pre-formed object being in a sol phase stateor an incomplete gel phase state during manufacturing.

[0036] The term “gel phase composition” as used herein, means thecomposition for making the pre-formed object being in a complete gelphase state during manufacturing.

[0037] The term “first surface” as used herein, means a lower surface ofthe pre-formed sheet during manufacturing, and after having beenpackaged.

[0038] The term “thickness” as used herein, means a thickness of apre-formed sheet, wherein when the sheet is textured, the peaks of thetexture are used for measuring the thickness.

[0039] The term “depth” as used herein, relates to a length in thethickness direction of a texture provided on the surface of a pre-formedsheet.

[0040] The term “frequency” as used herein, relates to the number ofrepeating non-planar topography per mm, the repetition of the non-planertopography providing a texture to the surface of a pre-formed sheet.

DETAILED DESCRIPTION

[0041] While the specification concludes with claims particularlypointing out and distinctly claiming the invention, it is believed thatthe present invention will be better understood from the followingdescription.

[0042] Pre-Formed Object

[0043] The pre-formed object provides structure and shape, allowing itto be handled and to suit treatment of a specific target area of theskin, hair or nails, or to be orally administered or consumed. It canalso act as a reservoir or as a delivery vehicle for skin benefit agentsand, when applied to the skin, hair or nails, by virtue of evaporationof a solvent from the pre-formed object, provide a cooling action to theobject during use. The pre-formed object may be utilized for a cosmeticproduct, a pharmaceutical product, or a food product, by itself, or incombination with other materials.

[0044] The pre-formed object is free of a supporting substrate. Theexistence of a supporting substrate provides various advantages duringmanufacture, by giving flexibility and strength to the pre-formedobject, and allowing ease of cutting the pre-formed object. The processof the present invention provides a suitable method of producingpre-formed objects without the aid of a supporting substrate.

[0045] The pre-formed objects have a plurality of surfaces that arecontinuously formed by pressing the sol phase composition againstliners, and then cut, to form a pre-determined size and shape. Theprocess herein can make any shape of object that is obtained by cuttinga continuous flow of material. Objects that are advantageously made bythe process herein include sheets, half-cylinders, and cylinders, andparticularly such objects that are textured on at least one surface.When the pre-formed object is for topical application, the size andshape are adapted to conform to a desired target area which could be thenails or cuticles, the hair or scalp, a human face or part thereof,legs, hands, arms, feet, or human torso. The exact size and shape willdepend upon the intended use and product characteristics.

[0046] Preferably, the pre-formed object has at least one surfacetextured. When the pre-formed object is a sheet, either or both of thefirst and second surfaces are textured. Preferably the first surface, orthe lower surface is textured. The texture for the surfaces herein areuseful for the production process, the characteristic of the obtainedproduct, or both, preferably for both. The texturing of the surface isuseful for determining and thus controlling the flow of the sol phasecomposition when passing through the surface forming system and coolingstep. The texturing of the surface may also provide various advantagesto the obtained product. For example, the texturing may provideflexibility, ease of handling, more adhesion to the skin for dermal use,a matte appearance to the object, or distinct mouth feel for oral use.The particular characteristics for the cosmetic device herein aredescribed below. The design, depth, and frequency of the texture isselected depending on the need of the process and character of theproduct. The texture is typically a regular repetition of pattern, andcan be generalized across a certain area, provided only for a given areasuch as the peripheral, or provided different textures depending on theregion. In a preferred pre-formed sheet embodiment, the texture isprovided to the entire area of the first surface, more preferably, thetexture is provided to the entire area of the first and second surfaces.

[0047] The pre-formed object made by the present invention is stable inmore than one aspect. The pre-formed object has a suitable gel strengthand a suitable flexibility, both characteristics having improvedconsistency over time at normal storage temperatures. Normal storagetemperature typically refers to room temperature, preferably 25° C.,however, when the pre-formed object is designed to be chilled or frozenon the shelf for display, stability should be assessed at the intendedstorage temperature.

[0048] When the pre-formed object is made of a composition that may gounder syneresis, stability is also measured by the exudates produced bythe pre-formed object over time. The pre-formed object made by thepresent invention produces less exudates than a composition made by, forexample, injection molding.

[0049] The composition for making the pre-formed objects comprise, asessential components, a solvent and a gelling agent having a sol-geltransition point between about the melting point of the solvent andabout the boiling point of the solvent. The weight percentage ofcomponents that make the composition are similar to that of the finallyobtained pre-formed object, with slight increase or decrease occurringduring the process, for example, loss of weight of water due toevaporation, or gain of weight of water due to hygroscopic components.For convenience, the weight percentage of components are referred to inview of the entire weight of the starting sol phase composition formaking the pre-formed object.

[0050] Solvent

[0051] The pre-formed objects of the present invention comprise asolvent for the gelling agent. The solvent is selected so that a solphase is made in combination with the gelling agent, wherein such solphase transitions into a gel phase between the melting point and boilingpoint of the solvent. Typically the gelling agent is at least misciblein the solvent at sol phase state for eventually providing a uniformunilamellar pre-formed object. The amount and type of solvent isdetermined to provide a stable gel phase with the gelling agent, in viewof the desired mechanical properties, particularly gel strength andflexibility, and also in view of the desired characteristic of theobtained product. Preferably, the solvent further acts as a plasticiseror softener for the pre-formed object.

[0052] For topical use, the pre-formed object comprises a hydrophilicsolvent. The term “hydrophilic” as used in reference to solvents herein,means that the solvent is miscible with water, at least in a solvent towater ratio of 1 to 10, preferably 1 to 5. A topical acceptable,hydrophilic solvent is one which can be used in a pre-formed object tobe applied against the skin without causing irritation and which ismiscible with water. A highly preferred hydrophilic solvent is wateritself. Other suitable hydrophilic solvents include lower alcohols suchas ethanol, and polyhydric alcohols such as propylene glycol, butyleneglycol, hexylene glycol, glycerin, sorbitol; polyethylene glycols of MWless than 30,000, preferably less than 10,000; and polypropylene glycolsof MW less than 5,000, preferably less than 1,000. Advantageously, manyof the polyhydric alcohols useful as hydrophilic solvents herein alsofunction as humectants for the skin. Further, the hydrophilic solventcan assist in diffusion of skin benefit agents to the skin and, byevaporation from the pre-formed object, can also provide cooling, makingthe pre-formed object more comfortable to wear. Preferred in this latterrespect are solvents which are liquid at 25° C. For topical use,preferably the solvent comprises water and at least one polyhydricalcohol, more preferably, the solvent consists essentially of water andpolyhydric alcohol.

[0053] In a preferred embodiment for providing a cosmetic device, thepre-formed object comprises from about 10% to about 99.5% of water, morepreferably from about 20% to about 95%, and yet more preferably fromabout 30% to about 90% of water. Still preferably, the pre-formed objectfurther comprises from about 1.0% to about 50%, preferably from about 5%to about 45%, more preferably from about 10% to about 40% of polyhydricalcohol.

[0054] For oral administration use, the solvent is selected from thegroup hereinabove that are safe, and preferably pleasing, for oralconsumption.

[0055] Gelling Agent

[0056] The pre-formed objects of the present invention comprises agelling agent having a sol-gel transition point between about themelting point of the solvent and about the boiling point of the solvent.The gelling agent is selected in view of the solvent so that thepre-formed object can be manufactured at a safe and economicalenvironment, and also to provide a pre-formed object that has a stablesolid structure at normal storage temperature. When the solventcomprises water, the sol-gel transition point of the gelling agent isbetween 0° C. and 100° C., preferably between about 25° C. and about 80°C., more preferably between about 35° C. and about 70° C. The processherein forms the pre-formed object via a thermo transitioning pointinherent of the solvent and the gelling agents. Gelling agents that donot form a sol phase in the solvent by elevated temperatures cannot beused in the process herein. Mixtures of gelling agents can be used.

[0057] The sol-gel transition point of the gelling agent is determinedby providing a sol phase composition using the selected gelling agentand solvent, and periodically measuring its storage modulus (unit Pa,hereinafter described as G′) and its loss modulus (unit Pa, hereinafterdescribed as G″) as the sol phase composition is cooled. The sol-geltransition point is the temperature where G′ equals G″. Such measurementmethods are well known to those skilled in the art. It is known thatgelling agents of natural origin, particularly gelling agents that aremixtures of natural polymers and have a viscoelastic nature, may providea sol-gel transition point that is not very sharp, or may go throughdistinctive rheological transition points other than at the sol-geltransition point before reaching a complete, stable gel structure. Theprocess of the present invention is particularly useful for providing astable gel structure for pre-formed objects including such gellingagents. The type and amount of gelling agent to be included in thepre-formed object is selected according to the desired characteristicand purpose of the product, depending on the properties of the gellingagent. Generally, more gelling agent will provide a more rigidpre-formed object. For providing food products or orally administrativeproducts, the gelling agent must be edible and acceptable in taste andflavor. Many types of gelling agents are known in the art, includingpolymeric gellants and particulate based gellants such as various typesof clays or other silicate based materials. Highly preferred herein arepolymeric gelling agents that form 3-dimensional gel networks incombination with water. For providing cosmetic devices, the pre-formedobject preferably comprises from about 0.5% to about 20%, morepreferably from about 1% to about 10%, of gelling agent. When thepolymeric gel forming agents are natural in origin, the gels may undergosyneresis, to some degree. In the present invention, stability relatesto pre-formed objects that undergo less syneresis, i.e., produces lessexudate. Pre-formed objects made by the present process particularlyproduce less exudates compared to compositions made by injectionmolding.

[0058] The gelling agents herein may be water soluble or waterinsoluble, and selected according to the solvent. When the solvent iswater or water-based, preferably the gelling agent is water soluble.Water insoluble polymeric gellants such as silicone materials e.g.organopolysiloxane resins, or block co-polymer thermoplastic elastomers,may be used in an appropriate solvent.

[0059] The water-soluble polymeric gellants for use in the presentinvention are selected from synthetic or natural polymers, and mixturesthereof. Preferred polymers for use herein are natural polymers,including gelatin, polysaccharides, and mixtures thereof. Preferred arepolysaccharides. The term “polysaccharide” herein means a naturallyoccurring or synthetically produced, linear, branched or cross-linkedpolymer of monosaccharide units, which swells when dispersed in water atlow concentrations and thickens the aqueous phase.

[0060] The polysaccharides for use in the pre-formed objects herein arepreferably selected from red seaweed polysaccharides; glucomannans;galactomannans; fermentation polysaccharides, or derivatives thereof;brown seaweed polysaccharides; extracts of marine invertebrates; starch,or derivatives thereof; natural fruit extracts; plant fiber derivatives;kelp; natural plant exudates; and resinous gums; or mixtures thereof.The total polysaccharide level is controlled so that other optionalcomponents of the pre-formed object are not as tightly bound within thegel network and are available for diffusion.

[0061] When gelatin is used in the pre-formed objects herein, ahigh-molecular weight gelatin is combined with a low-molecular weightone to control the solubility. A gelatin having a low molecular weightof 20,000 or less has weaker gelling ability when used as the solegelling agent.

[0062] Brown seaweed polysaccharides are isolated by extraction fromvarious species of Phaebophyceae. Suitable brown seaweed polysaccharidesfor use herein include algin, alginic acid, ammonium alginate, calciumalginate, potassium alginate, sodium alginate, propylene glycolalginate, and mixtures thereof.

[0063] Red seaweed polysaccharides are isolated from marine plantspecies belonging to the class of Rhodophyceae. Red seaweedpolysaccharides provide mechanical strength to the pre-formed object.Suitable red seaweed polysaccharides for use in the present inventioninclude agar known in the industry under the (CTFA) trade designation asagar agar flake derived from various Gelidium plant species or closelyrelated red algae commercially available as “Agar Agar 100” or “AgarAgar 150” from TIC Gums (Belcamp, Md., USA) or “Agar Agar K-100” fromGumix International Inc. (Fort Lee, N.J., USA); agarose commerciallyavailable as “Sea Plaque®” from FMC (Philadelphia, Pa., USA) and“Agarose Type 1-b” from Sigma-Aldrich Co. Ltd. (Poole, UK); carrageenan,comprising the fractions lambda-, iota- and kappa- which are the waterextracts obtained from various members of the Gigartinaceae orSolieriaceae families, known in the industry under the (CTFA) tradedesignation as chondrus, commercially available as “Gelcarin® LA”,“Seakem® 3/LCM”, or “Viscarin® XLV”, all from FMC (Philadelphia, Pa.,USA); and furcellaran commercially available from Gum TechnologyCorporation (Tucson, Ariz., USA) and Continental Colloids Inc. (Chicago,Ill., USA), or mixtures thereof. Preferably, the red seaweedpolysaccharide for use herein is selected from agar, agarose,kappa-carrageenan and furcellaran, or mixtures thereof.

[0064] Glucomannans are polysaccharides which comprise an essentiallylinear backbone of glucose and mannose residues. Glucomannans have shortside branches attached to the linear backbone and acetyl groups arerandomly present at the C-6 position of a sugar unit. The acetyl groupsare generally found on one per six sugar units to one per twenty sugarunits. Suitable glucomannans or derivatives thereof for use herein havea ratio of mannose to glucose of from about 0.2 to about 3. Preferredglucomannans for use herein include konjac mannan, which is the genericname for the flour formed from grinding the tuber root of theAmorphophallus konjac plant (elephant yam), commercially available underthe trade name “Nutricol® konjac flour” from FMC (Philadelphia, Pa.,USA); and deacetylated konjac mannan; or mixtures thereof.

[0065] Galactomannans are vegetable reserve polysaccharides which occurin the endosperm cells of numerous seeds of Leguminosae. The collectiveterm “galactomannan” comprises all polysaccharides which are built up ofgalactose and mannose residues. Galactomannans comprise a linearbackbone of (1→4)-linked β-D-mannopyranosyl units. To these rings areattached as branches, isolated galactopyranose residues byα-(1,6)-glucoside bonds. Galactomannans may in addition also containminor amounts of other sugar residues. Suitable galactomannans for useherein are fenugreek gum; lucern; clover; locust bean gum known forexample in the industry under the (CTFA) trade designation as carob beangum, commercially available as “Seagul L” from FMC (Philadelphia, Pa.,USA); tara gum commercially available from Starlight Products (Rouen,France) or Bunge Foods (Atlanta, Ga., USA); guar gum derived from theground endosperms of Cyamopsis tetragonolobus, commercially available as“Burtonite V7E” from TIC Gums (Belcamp, Md., USA), “Jaguar C” fromRhone-Poulenc (Marietta, Ga., USA), or “Supercol” from Aqualon(Wilmington, Del., USA); and cassia gum commercially available fromStarlight Products (Rouen, France), or mixtures thereof. Preferably, thegalactomannans for use herein have an average one of every 1 to about 5mannosyl units substituted with a (1→6)-linked-α-D-galactopyranosyl unitand are selected from guar gum, locust bean gum and cassia gum, ormixtures thereof.

[0066] Fermentation polysaccharides are polysaccharides which arecommercially produced by the fermentation of micro-organisms in a mediumcontaining a carbon and nitrogen source, buffering agent, and traceelements. Suitable fermentation polysaccharides or derivatives thereof,for use in the present invention include gellan gum known in theindustry under the (CTFA) trade designation as gum gellan, a highmolecular weight hetero polysaccharide gum produced by a pure-culturefermentation of a carbohydrate with Pseudomonas elodea, commerciallyavailable as “Kelcogel” from Kelco (San Diego, Calif., USA); xanthan gumwhich is a high molecular weight hetero polysaccharide gum produced by apure-culture fermentation of a carbohydrate with Xanthomonas campestris,known in the industry under the (CTFA) trade designation as xanthan,commercially available for example as “Keltrol CG1000/BT/F/GM/RD/SF/T/TF”, from Calgon (Pittsburgh, Pa., USA), or“Kelzan” from Kelco (San Diego, Calif., USA); natto gum; pullulan;rhamsan gum; curdlan; succinoglycan; welan gum; dextran, commerciallyavailable as “Sephadex G-25” from Pharmacia Fine Chemicals (Piscataway,N.J., USA) and derivatives thereof; and sclerotium gum, commerciallyavailable as “Amigel” from Alban Muller International (Montreil,France), or mixtures thereof. Preferred fermentation polysaccharides orderivatives thereof are selected from gellan gum and xanthan gum, ormixtures thereof. More preferably the fermentation polysaccharide orderivative thereof is xanthan gum.

[0067] Extracts of marine invertebrates can also be used.Polysaccharides derived from marine invertebrates, specifically theexoskeleton of such invertebrates, consist chiefly ofN-acetyl-D-glucosamine residues. Examples of such polysaccharidessuitable for use herein include chitosan, commercially available forexample as “Marine Dew” from Ajinomoto (Teakneck, N.J., USA); andhydroxypropyl chitosan commercially available for example as “HPCHLiquid” from Ichimaru Pharcos (Yamagata Gun Gifu-Pref, Japan) andderivatives; or mixtures thereof.

[0068] Starches are polysaccharides which consist of various proportionsof two glucose polymers, amylose and amylopectin. Suitable materials foruse herein include starch, amylopectin and dextrin, commerciallyavailable as “Nadex 360” from National Starch (Bridgewater, N.J., USA),and derivatives or mixtures thereof. Examples of natural fruit extractssuitable for use herein include pectin, arabian and mixtures thereof. Asuitable example of a plant fiber derivative for use herein iscellulose. Suitable polysaccharides obtained from natural plant exudatesfor use herein include karaya, tragacanth, arabic, tamarind, and ghattygums, or mixtures thereof. Examples of resinous gums suitable for useherein include shellac gum, which is obtained from the resinoussecretion of the insect Laccifer (Tachardia) lacca, damar gum; copal gumand rosin gum; or mixtures thereof. Natural and synthetic polymericgelling agents that form gels in combination with other substances, mayalso be used as a gelling agent in combination with other thermo-forminggelling agents, so long as the gel phase forming can been synchronized.They may be chemically cross linked. Some gelling agents form gels incombination with substances such as sugar, alcohol, or mono- ormulti-valent salts. Mono- or multi-valent salts may additionally act asgel strengthening agents imparting added strength to the pre-formedobjects herein. Suitable cations for such salts can be selected frompotassium, sodium, ammonium, zinc, aluminium, calcium and magnesiumions, or mixtures thereof. Suitable anions associated with theaforementioned cations may be selected from chloride, citrates, sulfate,carbonate, borate and phosphate anions, or mixtures thereof.

[0069] Physical cross linking refers to polymers having cross linkswhich are not chemical covalent bonds but are of a physical nature suchthat there are areas having high crystallinity or areas having a highglass transition temperature. Such cross linked polymers may also beused. Preferably, the polymer is chemically cross linked thermally. Inaddition when chemical cross links are formed in the system, apolyfunctional cross linker and/or a free radical initiator may bepresent in the premix to initiate the cross linking upon irradiation.

[0070] Preferably, the pre-formed objects herein comprise a mixture ofwater-soluble polymeric gelling agents of natural origin. A preferredwater-soluble polymeric gelling agent mixture herein may comprise apolysaccharide and a non-ionic water-soluble polymer or, alternatively,it may comprise two polysaccharides. More preferably, the water-solublepolymeric gel forming agent is a polysaccharide mixture, wherein thepolysaccharide mixture comprises (1) at least one red seaweedpolysaccharide; brown seaweed polysaccharide; or mixtures thereof; and(2) at least one fermentation polysaccharide; galactomannan;glucomannan; natural plant exudate; or natural fruit extract; andderivatives or mixtures thereof. Even more preferably, the water-solublepolymeric gel forming agent of the pre-formed objects of the presentinvention is a polysaccharide mixture comprising (1) at least one redseaweed polysaccharide; and (2) at least one fermentationpolysaccharide; glucomannan; or galactomannan; and derivatives ormixtures thereof.

[0071] In a preferred embodiment, the water-soluble polymeric gelforming agent of the present invention is a polysaccharide mixture,comprising a red seaweed polysaccharide and a glucomannan or agalactomannan. The ratio of red seaweed polysaccharide to glucomannan orgalactomannan in the polysaccharide mixture is preferably from about20:1 to about 1:5 and more preferably from about 10:1 to about 1:2.Without being limited by theory, it is believed that gel compositionsherein form 3-dimensional networks or matrices which bind or encapsulateother ingredients of the composition. Further, it has been found thatthis highly preferred polysaccharide mixture has a sol-gel transitionpoint at between about 35° C. and about 70° C. that is not very sharp,and has a second distinctive Theological transition point at betweenabout 20° C. and about 50° C. It has been found that the compositioncomprising the highly preferred polysaccharide mixture forms a stablegel structure after being cooled below such second transition point. Theprocess of the present invention is particularly useful for such highlypreferred polysaccharide mixture. In a highly preferred embodiment, thegel phase composition is cooled well below the second transition pointin the cooling process. By cooling the gel phase composition to suchextent, a pre-formed object having stability in terms of gel strength,flexibility, and reduced exudates is obtained.

[0072] Cosmetic Device

[0073] In a highly preferred embodiment, the pre-formed object of thepresent invention is a sheet-like cosmetic device for delivering skinbenefit agents to the skin hair or nails. Herein, the term “pre-formedsheet” is used to describe such sheet-like pre-formed object. Apre-formed sheet is a preferable embodiment of the pre-formed objectherein.

[0074] The cosmetic device of the present invention comprises apre-formed sheet made by the process described below, and may furthercomprise a coating composition. The coating composition may be includedin the same package as the pre-formed sheet to reach equilibrium in thepackage. Such application step of the coating composition onto thepre-formed sheet may be disposed in a continuous manner of making thecosmetic device. Cosmetic devices according to the present invention aregenerally of a size such that each surface has an area of from about0.25 cm² to about 1,000 cm², preferably from about 1 cm² to about 300cm². Surface area refers to that of a flat plane having the sameboundary as the surface i.e. ignoring any surface texturing present.

[0075] The cosmetic devices herein can be, for example, square,circular, semicircular, rectangular, oval, rings, crescents, teardropsor other more complex shapes which may be composites of these, forcovering areas such as the eye area, eye lids, the nose, the mouth area,the forehead, the chin, the entire contour of the face, or combinationsthereof.

[0076] Coating Compositions

[0077] In the pre-formed sheet of the present invention, the firstsurface is at least partially coated with a discrete coating compositioncomprising at least one skin benefit agent for the skin, hair or nails.By “discrete” coating composition is meant one that is applied to thepre-formed sheet as a distinctly different composition, in particularone having a different chemical constitution which is separatelyprepared from the pre-formed sheet and is laid down as a separate layer,before, after or at the same time as the formation of the pre-formedsheet. The coating composition allows more efficient delivery of skinbenefit agents to the skin and affords greater formulation flexibility.

[0078] The coating composition comprises at least one skin benefit agentfor the skin, hair or nails. Preferably, the pre-formed sheet and thecoating composition each comprise at least one skin benefit agent incommon. In this way, whilst the coating composition can rapidly providea skin benefit agent to the target area, the pre-formed sheet can act asa reservoir for the skin benefit agent or inhibit the pre-formed sheetfrom absorbing the skin benefit agent from the coating composition.

[0079] Skin Benefit Agents

[0080] In a highly preferable embodiment, the cosmetic device of thepresent invention comprises a coating composition which comprises atleast one skin benefit agent for the skin hair, or nails. The solidpre-formed sheet preferably also comprises one or more of such skinbenefit agents. The term “skin benefit agent” as used herein, means anactive ingredient which provides a cosmetic and/or therapeutic effect tothe area of application on the skin, hair, or nails. The skin benefitagents useful herein include anti-acne agents, emollients, non-steroidalanti-inflammatory agents, topical anaesthetics, artificial tanningagents, antiseptics, anti-microbial and anti-fungal actives, skinsoothing agents, sunscreening agents, skin barrier repair agents,anti-wrinkle agents, anti-skin atrophy actives, lipids, skin lighteningagents, sebum inhibitors, sebum inhibitors, skin sensates, proteaseinhibitors, skin tightening agents, anti-itch agents, hair growthinhibitors, desquamation enzyme enhancers, anti-glycation agents, andmixtures thereof.

[0081] In general, the coating compositions of the present inventioncomprise from about 0.01% to about 60%, preferably from about 0.1% toabout 40% and most preferably from about 0.5% to about 30% by weight ofthe coating compositions of at least one skin benefit agent, or mixturesthereof.

[0082] Preferred examples of skin benefit agents useful herein includethose selected from the group consisting of ascorbic acid andderivatives thereof, salicylic acid, niacinamide, panthenol, tocopherylnicotinate, benzoyl peroxide, 3-hydroxy benzoic acid, flavonoids (e.g.,flavanone, chalcone), farnesol, phytantriol, glycolic acid, lactic acid,4-hydroxy benzoic acid, acetyl salicylic acid, 2-hydroxybutanoic acid,2-hydroxypentanoic acid, 2-hydroxyhexanoic acid, cis-retinoic acid,trans-retinoic acid, retinol, retinyl esters (e.g., retinyl propionate),phytic acid, N-acetyl-L-cysteine, lipoic acid, tocopherol and its esters(e.g., tocopheryl acetate), azelaic acid, arachidonic acid,tetracycline, ibuprofen, naproxen, ketoprofen, hydrocortisone,acetominophen, resorcinol, phenoxyethanol, phenoxypropanol,phenoxyisopropanol, 2,4,4′-trichloro-2′-hydroxy diphenyl ether,3,4,4′-trichlorocarbanilide, octopirox, lidocaine hydrochloride,clotrimazole, miconazole, ketoconazole, neomycin sulfate, theophylline,and mixtures thereof.

[0083] For cosmetic methods of treatment of the skin, hair or nails, thecosmetic skin benefit agent is preferably selected from anti-wrinkle andanti-skin atrophy actives, anti-acne actives, artificial tanning agentsand accelerators, emollients, humectants, skin repair actives, skinbarrier repair aids, skin lightening agents, skin sensates, skinsoothing agents, lipids, sebum inhibitors, sebum stimulators,sunscreening agents, protease inhibitors, skin tightening agents,anti-itch ingredients, and desquamation enzyme enhancers, or mixturesthereof.

[0084] The pH of the pre-formed sheets and coating compositions hereinis preferably from about 3 to about 9, more preferably from about 4 toabout 8. The pH may be selected depending on the activity of the skinbenefit agent.

[0085] Process of Manufacturing the Pre-Formed Object

[0086] The process for making a pre-formed object having a plurality ofsurfaces of the present invention relates to a continuous line processcomprising the steps of:

[0087] (1) providing a sol phase of the composition comprising a solventand a gelling agent having a sol-gel transition point between about themelting point of the solvent and about the boiling point of the solvent;

[0088] (2) forming surfaces of the sol phase composition by passingthrough a surface forming system, the surface forming system pressingthe sol phase composition between a plurality of liners;

[0089] (3) cooling the sol phase composition into a gel phase; and

[0090] (4) cutting the gel phase composition;

[0091] wherein the pre-formed object is free of a supporting substrate.

[0092] The process of the present invention relates to forming thepre-formed object via cooling. The process herein is suitable forproviding a continuous flow of material for making the pre-formedobject, and thus can be suitably applied to large scale manufacturing.The process herein may be used for making pre-formed objects comprisingany gelling agent having a sol-gel transition point, however, isparticularly useful for gelling agents that do not have a sharp sol-geltransition point, or have rheological transfer points other than thesol-gel transition point. In this respect, the process herein isparticularly useful for making pre-formed objects comprising a mixtureof gelling agents of natural source.

[0093] The present invention further relates to a continuous lineprocess for making a pre-formed sheet having a first surface and asecond surface comprising the steps of:

[0094] (1) providing a sol phase composition of the pre-formed sheetcomprising:

[0095] (a) from about 10% to about 99.5% water; and

[0096] (b) from about 0.5% to about 20% polysaccharide gelling agenthaving a sol-gel transition point between about 25° C. and about 80° C.;

[0097] wherein the sol phase composition is heated to a temperature ofat least 5° C. higher than the sol-gel transition point;

[0098] (2) pre-cooling the sol phase composition to a temperature ofbetween 0° C. and 5° C. higher than the sol-gel transition point;

[0099] (3) forming the first and second surfaces by pressing the solphase composition between two liners, the two liners being supplied bytwo counter-rotating rollers facing each other, wherein the rollersfurther comprise cooling means, wherein the two liners further providetextures to the first and second surfaces;

[0100] (4) cooling the sol phase composition into a gel phase by coolingto no higher than 20° C.; and

[0101] (5) cutting the gel phase composition by a die;

[0102] wherein the pre-formed sheet is free of a supporting substrateand the pre-formed sheet has a flex angle of from about 15° to about80°.

[0103] In a preferred continuous line process, all of the manufacturingsteps from sol phase making to finished product packaging are disposedin a continuous line with speed buffer means and transfer means to carrymaterial to a different line, as necessary.

[0104] The present invention further relates to a process for providinga packaged cosmetic device comprising: a pre-formed sheet and a coatingcomposition comprising a skin benefit agent; comprising the steps of:

[0105] (1) providing a unsealed package;

[0106] (2) applying the coating composition in the package;

[0107] (3) placing the pre-formed sheet in the package; and

[0108] (4) sealing the package;

[0109] wherein the steps are in communication with each other to providea continuous line process.

[0110] As the preferred pre-formed sheets herein utilize water as thesolvent, the pre-formed sheet is relatively vulnerable to change ofhumidity, particularly excessive or rapid drying. Drying beyond acertain extent, depending on the composition, will decompose or deformthe pre-formed object by destroying its gel structure. Therefore, in theprocess herein, it is advantageous to dispose the packaging means forthe cosmetic device such that the pre-formed sheet is immediatelypackaged and sealed after production.

[0111]FIG. 1 schematically depicts a process, in functionalperspectives, for making a preferred cosmetic device embodimentcomprising a pre-formed sheet having a composition selected from one ofTable 1 and a coating composition selected from one of Table 2, whereinthe cosmetic device is packaged in a blister package.

[0112] While the process of the present invention may be used to formany number of surfaces, the process for making a pre-formed sheet havinga first surface and a second surface for the preferred cosmetic deviceembodiment is illustrated herein. TABLE 1 Compositions for Pre-formedSheet Ingredient % w/w % w/w % w/w % w/w Agarose 0.3 0.8 1.6 1.5 Agar 0.60 — — — Kelgum (Kelco)¹ — 0.5 0.8  0.75 Keltrol T (Kelco)¹ 0.2 — — —Locust Bean Gum 0.2 — — — Niacinamide — 5.0 8.0 10.0  D-Panthenol 5.0 —2.0 1.0 Glycerin 10.0  15.0  10.0  10.0  Disodium EDTA —  0.10  0.10 0.10 Butylene Glycol — 5.0 — — Hexylene Glycol 3.0 — 5.0 5.0 EthylParaben  0.20  0.15  0.15  0.15 Water to 100% to 100% to 100% to 100%

[0113] TABLE 2 Coating compositions Ingredient % w/w % w/w % w/w % w/w %w/w Kelgum (Kelco)¹ 0.1 — — — — Keltrol T (Kelco)¹ — 0.5 0.9 — 0.8Locust bean gum 0.4 — — — — Polyacrylamide, isoparaffin & laureth-7 — ——  2.75 — Niacinamide 5.0 — 8.0 3.5 10.0 D-Panthenol — 5.0 2.0 2.0 1.0Glycerin — 5.0 10.0  9.0 10.0  Disodium EDTA  0.10 0.1 0.1 0.1 0.1Butylene glycol — 5.0 — — — Hexylene glycol — — 5.0 — 5.0 Tospearl ™145² — — 6.0 1.0 7.5 DC 2-1559 emulsion³ — — 3.0 4.0 3.0 Magnesiumascorbyl phosphate 3.0 — — — — Tocopheryl acetate 0.5 — —  0.75 — PEG-60hydrogenated castor oil  1.50 — — — — Cetyl alcohol — — — 1.5 — Stearylalcohol — — — 1.0 — Lonzaine ™ 16SP⁴  0.47 — — — — Tinoderm ™ E⁵ — — — —10.0  Sucrose cocoate and sorbitan stearate⁶ — — — 1.0 — Isohexadecane —— — 2.0 — Isopropyl isostearate — — — 1.0 — SEFA cottonate — — — 1.0 —Petrolatum — — — 3.0 — Water, fragrance, preservatives to 100%

[0114] Referring to FIG. 1, the process of the present invention formaking the pre-formed sheet is generally described as the pre-formedsheet making line. The coating composition is prepared separately, andsupplied to the cosmetic device packaging line, wherein the unsealedblister package receives the coating composition, followed by receivingthe transferred pre-formed sheet, to make a cosmetic device. Thecosmetic device is then sealed. The blister package is typicallysupplied in plurality as a continuous sheet of thermoformed material.After the cosmetic device is received and sealing is provided, thecontinuous packaging material is cut into unit application forms. Thepre-formed sheet making line is depicted in detail in FIG. 2.

[0115] Referring to FIG. 2, the process of the present invention startsby providing a sol phase of the composition, in this embodiment, thecomposition of one of Table 1. The sol phase making step (10) istypically conducted by mixing the components of the pre-formed sheet ina tank (11) at a temperature well above the sol-gel transition point,preferably at least 5° C. higher than the sol-gel transition point. Inthis embodiment, the sol phase making is conducted at elevatedtemperature with the aid of stirring (12). The stirring is kept to adegree so that the structures of the polymeric gelling agents per se arenot destroyed.

[0116] Preferably, the sol phase composition is pre-cooled before beingsent to the sheet forming system. In the pre-cooling step (13), the solphase composition is cooled to a temperature still above, but closer tothe sol-gel transition point, for example by means of placing in apre-sheet forming tank (14). Preferably, the sol phase composition iscooled to a temperature of between 0° C. and 5° C. higher than thesol-gel transition point. It has been found that, with the aid ofstirring (15), the sol phase composition can retain the sol phase at thesol-gel transition point temperature.

[0117] The pre-cooled sol phase composition is then delivered to thesurface forming system, in this embodiment, the sheet forming system(20). The sheet forming system is preferably a mechanical pressuring ofthe sol phase composition against two hard surfaces facing each other,such as counter-rotating rollers or plates facing each other. Passing ofthe sol phase system through counter-rotating rollers are preferred inthat it allows continuous flow of the line. When a pair of opposingplates is used for the surface forming system, the continuity of flowcan be provided by allowing intervals during the pressing of a givenarea for a determined period of time. In this embodiment, the sol phasecomposition is poured at a controlled rate between the first liner (22)and the second liner (23) supplied by two counter-rotating rollers (21)which supply the liners.

[0118]FIG. 3 is a schematic view of a preferred embodiment of thesurface forming system of the present invention, with the thickness ofthe liners and depths of textures inflated. Referring to FIG. 3, the solphase composition (200) which is in a fluid state is directed betweenthe first liner (202) and the second liner (203), wherein mechanicalpressure is applied to the sol phase composition by the rotating actionof the rollers. In order to direct the sol phase composition to theengaging point of the rotating rollers, the sol phase composition may bepoured at the engaging point, or poured at one of both of the liners tobe delivered to the engaging point. In this embodiment, the sol phasecomposition travels vertically in the surface forming system, however,the surface forming system may also be configured horizontally.Preferably the first liner is textured to provide a non-planertopography, more preferably the second liner is further textured toprovide a non-planer topography. In this embodiment, both liners providetextures of regular frequency. Such textures are transferred to the solphase composition via mechanical pressure applied to the sol phasecomposition (212, 213), and preferably by further cooling of the solphase composition while passing the liners in contact with thecounter-rotating rollers, wherein the rollers (201) encompass a coolingmeans, typically a continuous running of cold water. As the liners areunwound from the counter-roating rollers, the partially formed sol phasecomposition which is adhered to the two liners are released from thepressure of the counter-rotating rollers, to travel to the next step.

[0119] The liners herein are thin enough to provide effective cooling,while thick enough to retain its mechanical strength and texturedefinition through the process. The material for the liners are selectedin view of heat conductivity, rigidity, elasticity, adhesion to the solphase composition, and inertness of the gel phase composition. In thisembodiment, preferred liners are made of polyethylene and have athickness of from about 10 μm to about 50 μm. Referring to FIG. 2, whentextured liners are used, the liners may be formed to the desiredtexture by a pressing against an embossing roller (24) with the aid ofheat prior to supplying to the surface forming system. The embossingprocess for the liners may be conducted discontinuous to the lineprocess herein. The same may be applied to the second liner.

[0120] The preferred surface forming system herein is advantageous inmany ways for providing pre-formed sheets having textured surfaces, freeof a supporting substrate. For example, the sol phase composition wouldbe effectively cooled so that at least the surfaces of the compositionin contact with the liners would quickly transition to a harder state orpartial gel phase, thereby ensuring well defined textures at thesurfaces. Further, control of the overall line flow of the compositionis improved, as the gelled or solidified surface would be lesssusceptible to process vibration and movement of the liner. Further, theentire process line can be rationalized, as less subsequent coolingwould be necessary, thereby leading to shorter lines or faster process.The speed in which the sol phase composition passes the surface formingsystem is carefully adjusted so that the surfaces are soft enough to betextured, but having solid enough surfaces after leaving the system.

[0121] In the process herein, the composition which is partially gelledor gelled only in local areas, particularly the surfaces, are defined asa sol phase composition. It is typical that the composition leaving thesurface forming system is still a sol phase composition, even if thesurface of the composition is below the sol-gel transition point.

[0122] The process of the present invention provides stable pre-formedsheets having a thickness of about 0.1 mm to about 5 mm with relativelydeep texture depths, as deep as about 10 μm to about 500 μm, dependingon the thickness of the pre-formed sheet. In a particularly preferredembodiment, the pre-formed sheet has a thickness of about 0.5 mm toabout 2.0 mm, and a texture depth of from about 50 μm to about 200 μm atthe first and second surfaces. Such specific texturing of the surfacesmay provide various advantages to the cosmetic device comprising thepre-formed sheet, which are described below.

[0123] Referring to FIG. 2, the partially solidified sol phasecomposition, which may be partially gelled, is then directed to thecooling system (30) for completely transitioning the composition into agel phase. In this embodiment, the cooling is achieved by direct coolingsuch as by cooling plates (31) and chilled rollers (32), andadditionally by indirect cooling such as by placing the line in acooling chamber (33). In this embodiment, the composition is cooled tothe extent the entire sheet is transitioned to a complete stable gelphase.

[0124] The speed of cooling at the surface forming step and the coolingstep are important factors of the process herein for obtaining a stablegel phase for the pre-formed sheet. The speed will depend on thecomposition for the pre-formed sheet, particularly on the rheologicalbehaviors of the composition during the process. For this embodiment,the rate of cooling is preferably from about 5° C. to about 100° C. perminute, more preferably from about 10° C. to about 50° C. per minute.Generally, the speed of cooling is much faster when the pre-formed sheetis made by injection molding processes. Particularly for pre-formedsheet embodiments that use natural gelling agents, the slower coolingachieved in the process herein is beneficial for providing a stableproduct.

[0125] The gel phase composition thus obtained is then cut (40) into itspredetermined size and shape to obtain the pre-formed sheet. The linerin contact with the second surface may be removed (42) prior to thecutting step. The liner in contact with the first surface is preferablykept intact until after the cutting step. The cutting can be conductedby any means known in the art. For effective cutting in a continuousline process, cutting is preferably conducted by vertical movement of adie, preferably by rotating a roller having the dies disposed on thesurface (41). The preferred cutting step of the present invention isalso advantageous for effectively providing pre-formed sheets havingrelatively deep texture depths on the first surface. In the preferredembodiment for making a cosmetic device, both surfaces of the pre-formedsheet are textured in a regular pattern.

[0126]FIG. 4 is a schematic view of a preferred embodiment of thecutting system of the present invention, with thickness of the linersinflated. Referring to FIG. 4, the blades of the die (401) enter fromthe second surface toward the edge of the first surface (402) forvertically cutting the pre-formed sheet. The extent of cutting is socontrolled that the edge of the blade of the die (403) reaches beyondthe bottom (404) of the texture of the first surface, however, does notreach beyond the peak (405) of the texture of the first surface. It hasbeen surprisingly found that, even when the edge of the die blade doesnot completely cut the thickness of the sheet such as in the area shownas 406, such area can be cut without additional process steps. The area406, where the die blade does not reach, is cut by the shear applied bythe movement of the die blade, or by forcing the pre-formed sheet totear off upon transferring the pre-formed sheet, or both, withoutaffecting the shape or stability of the obtained pre-formed sheet.

[0127] Referring to FIG. 2, the finally obtained pre-formed sheet isfurther transferred for packaging by, for example, an arm with suctionmeans (51) which removes the pre-formed sheets away from the liner incontact with the first surface. Effective and convenient packaging canbe conducted by releasing the sucked pre-formed sheet and placing intothe package, followed by sealing of the package. In this embodiment, thepre-formed sheet is placed into a blister package in this manner,wherein the first surface remains the lower surface in the package, thesecond surface to face the sealing of the package.

[0128] The coating composition for the cosmetic device is separatelymade. A variety of methods are suitable for applying the coating to thepre-formed sheet in order to form the finished cosmetic device. Forexample, the coating may be applied directly to the pre-formed sheete.g. dispensed via a pipette to provide ‘dots’ of coating or spread witha brush to provide an uniform layer. Alternatively, the coating may beapplied using screen printing techniques or via an extrusion process.The coating may also be applied to the pre-formed sheet via an indirectprocess. Referring to FIG. 1, in this embodiment, the coatingcomposition is applied to a surface of the blister package, and then thepre-formed sheet is placed on top of the coating composition. A varietyof methods may be used to apply the coating to the packaging material.These include air atomised spraying of the coating, dot deposition ofthe coating via a nozzle cosmetic device or an electrofluidic coatingprocess of the type used in ink jet printing. A preferred method is dotdeposition of the coating composition into a packaging tray usingnozzles, swirling the nozzles to provide an uniform layer of coating,then pressing the pre-formed sheet onto the top of the coatingcomposition.

[0129] The packages for the cosmetic device embodiment herein is made ofmaterials which have low water vapor permeability to minimize drying outof the cosmetic device during storage. Any suitable material can be usedfor the packaging such as plastics materials and foil laminates. Thisprotection can be provided by a substrate or by a release liner such asa plastic film, which provides easy release upon using the cosmeticdevice.

[0130] An embodiment of the pre-formed sheet for the cosmetic devicemade by the process of the present invention is shown in perspective inFIG. 5 wherein the first surface is shown on top. The pre-formed sheetis broadly crescent shaped, of dimensions such that a notional rectangleof 4 cm×2 cm bounds the crescent, and the first surface has repeatingdiamond shaped convexes which provide a distinct texture. Provided insection view as in FIG. 7, the cosmetic device (1) comprises apre-formed sheet (2) and coating composition (3) on a first surface (4)of the pre-formed sheet. The pre-formed sheet is generally flat having auniform thickness. The pre-formed sheet has a second surface (5) opposedto the first surface (4). The pre-formed sheet by the process hereindoes not have distinct rims at the peripheral. However, it has beensurprisingly found that, even without the rims, the pre-formed sheet ofthe present invention provides enough strength to the cosmetic devicefor handling at regular conditions.

[0131] Key parameters for evaluating the physical characteristics of theobtained cosmetic device are gel strength and flexibility. Flexibilityfor the cosmetic device herein is measured by how much the device bendsunder its own weight when it overhangs an edge at its most flexiblesurface. Minimum required gel strength is confirmed by checking if thedevice does not rupture under its own weight when overhanging. A 4 cm by2 cm rectangular, test strip of the pre-formed sheet is prepared. Forcosmetic devices of the present invention which comprise the pre-formedsheet and a coating composition, the test strip should be evenly coatedwith the coating composition at a rate of 0.015 g/cm², and should bemeasured at 25° C. The strip, coated first surface uppermost, issupported on a flat surface, having a rectangular edge so that 2 cm ofthe 4 cm length of the strip can overhang without obstruction. Thearrangement is shown schematically in FIG. 8. Test strip (6) (coatingcomposition not shown) overhangs the vertical edge of solid support (7),whose upper surface is horizontal. The angle θ of overhang from thevertical is measured by drawing a straight line (shown as a dashed linein FIG. 8) from the tip of the gel sheet to the edge of the support.This can conveniently be done from a photograph. The test strip shouldnot rupture upon overhanging. The angle of overhang, θ, is the flexangle of the composition. The test strip should have a flex angle offrom about 15° to about 80°, preferably from about 25° to about 75° andmore preferably from about 40° to about 60°. The present inventionfurther relates to a cosmetic device comprising:

[0132] (1) a pre-formed sheet comprising:

[0133] (a) from about 10% to about 99.5% water; and

[0134] (b) from about 0.5% to about 20% polysaccharide gelling agenthaving a sol-gel transition point between about 25° C. and about 80° C.;

[0135] wherein the pre-formed sheet is free of a supporting substrate,has a thickness of from about 0.1 mm to about 5 mm, preferably fromabout 0.5 mm to about 2.0 mm and a first surface and a second surface,the first surface having a repeating texture having a depth of fromabout 10 μm to about 500 μm, preferably from about 50 μm to about 200 μmat a frequency of from about 0.2 to about 1 per mm, preferably fromabout 0.3 to about 0.7 per mm; wherein the depth of the texture is atleast about 10% of the thickness of the pre-formed sheet; and

[0136] (2) a coating composition comprising a skin benefit agent andhaving a viscosity of from about 1000 mPa.s to about 30,000 mPa.s,preferably from about 5000 mPa.s to about 15,000 mPa.s;

[0137] wherein the repeating texture is so designed to provide a networkof channels that allows fluid communication of the coating compositionwhen the first surface is worn on the skin.

[0138] Preferred embodiments of the pre-formed sheet compositions aredescribed in Table 1 above. More preferably, the pre-formed sheets aremade by the process described above. The coating composition can beaqueous solutions, including gels, or emulsions such as oil-in-wateremulsions, water-in-oil emulsions or multiple emulsions having aqueousor oily external phases. Preferred embodiments are described in Table 2above, all of which have a viscosity of between about 5000 mPa.s andabout 15,000 mPa.s. The viscosity of the coating composition is measuredon a Brookfield viscometer using a heliopath T-bar C spindle at 5 rpm.

[0139] The weight ratio of the coating composition to the pre-formedsheet is generally more than about 1:50, preferably from about 1:25,more preferably from about 1:15 to about 10:1. Preferred dosage rates ofthe coating compositions on the pre-formed sheet can alternatively beexpressed as from about 0.001 to about 0.2 g/cm², preferably from about0.005 to about 0.05 g/cm². Generally, the coating composition covers atleast about 20%, preferably at least about 50%, more preferably at leastabout 75% of the area of the first surface.

[0140] The cosmetic device herein can be made by any suitable process,preferably, by the process as described herein. In the embodiment above,the pre-formed sheet is placed into a blister package so that the firstsurface remains the lower surface in the package, the second surface toface the sealing of the package. Such packaging is advantageous for thecosmetic device herein. It is the intention that the wearer would removethe cosmetic device from the packaging with the fingers engaging thesecond surface, and then applying the first surface to the skin.

[0141] It has been surprisingly found that, by providing a certainthickness to the pre-formed sheet, and texture of certain depth andfrequency to the first surface of the pre-formed sheet, the cosmeticdevice provides various benefits for the wearer of the cosmetic device.FIG. 6 is an enlarged, partially segmented perspective view of the firstsurface vicinity of a preferred embodiment of the pre-formed sheet ofthe present invention. Referring to FIG. 6, the first surface of thepre-formed sheet has a repeating texture that provides a network ofchannels (601). Despite the cosmetic device comprises a coatingcomposition (not shown) of low viscosity, the pre-formed sheet can beconveniently adhered to the skin by applying the first surface to theskin. It has been surprisingly found that, with the elements above, thecosmetic device provides adequate adhesion to the skin such that, evenwhen worn in a vertical manner, the cosmetic device does not easily dragdown the skin. Without being bound by theory, it is believed that thenetwork of channels that allow fluid communication of the coatingcomposition provides an even distribution of the coating compositionpredominantly in the channels of the texture, thereby allowing theremaining wearer contacting area (610) of the texture to effectivelyadhere to the skin. Referring to FIG. 5, a highly preferred embodimentof the wearer contacting areas is depicted as the plurality of diamondshaped convexes. Referring back to FIG. 6, when the coating compositionis excess the amount that can be carried in the channels, the network ofchannels also allows discretion of the coating composition to theperipheral (602) of the pre-formed sheet thereby allowing the coatingcomposition to flow away from, or evaporate from the area of the skin onwhich the cosmetic device is applied. Thus, after the cosmetic device isworn on the skin, the coating composition immediately evenly distributesthroughout the area on which the cosmetic device is worn, leaving thediscontinuous, spaced wearer contacting areas more or less vacuum. Thus,the cosmetic device is sucked onto the skin. For such effective suckingof the cosmetic device on the skin, the pre-formed sheet is preferablyuniform in thickness. The channels further provide a reservoir of thecoating composition between the pre-formed sheet and the skin, thusallowing continuous contact of the coating composition to the skin sothat the skin benefit agents are effectively delivered to the skin.

[0142] Providing rims around the peripheral of the pre-formed sheet hasbeen proposed for increasing the strength of the pre-formed sheet. Ifthe rim is overly distinct such that it interferes with the fluidcommunication of the channels, the rims may negatively affect thesuction effect herein. Thus, when rims are provided to the pre-formedsheet, they are kept to a modest thickness and in a manner that providecontinuity to the channels.

[0143] Preferably, the second surface of the pre-formed sheet also has arepeating texture having a depth of from about 10 μm to about 500 μm,preferably from about 50 μm to about 120 μm at a frequency of from about0.2 to about 1 per mm, preferably from about 0.3 to about 0.7 per mm.Texturing on the second surface is also advantageous to the wearer. Thefirst surface is intended to be applied to the skin. Upon removing thecosmetic device from the package, the wearer would engage the fingers onthe second surface. The texturing of the second surface will help thisengagement. Further, even if the wearer applies the second surface onthe skin, the texturing of the second surface will provide similareffects as expected by the first surface. Further, from an aestheticpoint of view, texturing on both surfaces provides a matte, less shinyappearance to the cosmetic device, thereby the cosmetic device is moreor less invisible upon application to the skin.

[0144] Methods of Use

[0145] The cosmetic device of the present invention is applied to atarget area of the skin, hair or nails, and will generally be left onthe target area for at least 1 minute, preferably at least 5 minutes, itcan be left on for a period of up to 12 hours, preferably up to 3 hours,more preferably up to 1 hour, though most preferably for less than 30minutes. The cosmetic device can then be removed in one piece.Preferably, the first surface is worn on the skin. In one embodiment,the cosmetic device may comprise the coating composition in excessamount, wherein the excess coating composition is first applied to theentire surface of the face, followed by applying the cosmetic device toa specific area of the face where intensive treatment is desired.

[0146] Depending on the skin benefit agent contained therein, thepre-formed, cosmetic devices of the present invention may have at leastone of the following uses; hydrating the skin, hair or nails, smoothingfine lines and wrinkles; cosmetically treating acne; firming orsoftening the skin, strengthening; softening; exfoliating; improvingand/or evening skin tone and/or texture; skin, hair or nail lightening;tanning; reducing the appearance of pores; absorbing or controllingsecretions; protecting and/or soothing the skin, hair or nails, muscles,aches or pains; reducing puffiness, and/or dark circles; stimulatingwound healing; warming, refreshing or cooling the skin, hair or nails;relieving inflammation; brightening the complexion; decongesting;reducing swelling; treating dermatological conditions; cushioning;purifying; fragrancing; reducing bacterial or micro-organism growth;healing; repelling insects; removing unwanted hair, dirt, or make-up;and coloring or bleaching the target area to which the cosmetic deviceis applied. Preferably, the pre-formed sheets herein are cosmeticallyused for hydrating the skin, hair or nails; smoothing fine lines andwrinkles; improving and/or evening the skin tone and/or texture; andfirming or softening of the skin.

[0147] It is understood that the foregoing detailed description ofexamples and embodiments of the present invention are given merely byway of illustration, and that numerous modifications and variations maybecome apparent to those skilled in the art without departing from thespirit and scope of the invention; and such apparent modifications andvariations are to be included in the scope of the appended claims.

What is claimed is:
 1. A continuous line process for making a pre-formedobject having a plurality of surfaces comprising the steps of: (1)providing a sol phase composition comprising a solvent and a gellingagent having a sol-gel transition point between about the melting pointof the solvent and about the boiling point of the solvent; (2) formingsurfaces of the sol phase composition by passing through a surfaceforming system, the surface forming system pressing the sol phasecomposition between a plurality of liners; (3) cooling the sol phasecomposition into a gel phase; and (4) cutting the gel phase composition;wherein the pre-formed object is free of a supporting substrate.
 2. Theprocess of claim 1 wherein the surface forming system comprises acooling means.
 3. The process of claim 2 wherein the pre-formed objectis a sheet having a first surface and a second surface, wherein thefirst and second surfaces are formed by pressing the sol phasecomposition between two liners, the two liners being supplied by twocounter-rotating rollers facing each other.
 4. The process of claim 3wherein the rollers are chilled for providing the cooling means.
 5. Theprocess of claim 3 wherein at least the first surface is textured bypressing the sol phase composition against the liner, the liner having atexture that is transferable to the sol phase composition.
 6. Theprocess of claim 5 wherein the texture is provided to the entire area ofthe first surface.
 7. The process of claim 5 wherein the second surfaceis textured.
 8. The process of claim 5 wherein the pre-formed sheet iscut by a die entering from the second surface toward the first surface,wherein the die blade does not reach beyond the peak of the texture ofthe first surface.
 9. The process of claim 1 wherein the sol phasecomposition is pre-cooled prior to the surface forming system.
 10. Theprocess of claim 1 wherein the cooling step comprises a direct coolingmeans and an indirect cooling means.
 11. The process of claim 3 whereinthe pre-formed sheet has a flex angle of from about 15° to about 80°.12. A continuous line process of claim 1 for making a pre-formed sheethaving a first surface and a second surface comprising the steps of: (1)providing a sol phase composition of the pre-formed sheet comprising:(a) from about 10% to about 99.5% water; and (b) from about 0.5% toabout 20% polysaccharide gelling agent having a sol-gel transition pointbetween about 25° C. and about 80° C.; wherein the sol phase compositionis heated to a temperature of at least 5° C. higher than the sol-geltransition point; (2) pre-cooling the sol phase composition to atemperature of between 0° C. and 5° C. higher than the sol-geltransition point; (3) forming the first and second surfaces by pressingthe sol phase composition between two liners, the two liners beingsupplied by two counter-rotating rollers facing each other, wherein therollers further comprise cooling means, wherein the two liners furtherprovide textures to the first and second surfaces; (4) cooling the solphase composition into a gel phase; and (5) cutting the gel phasecomposition by a die; wherein the pre-formed sheet is free of asupporting substrate and the pre-formed sheet has a flex angle of fromabout 15° to about 80°.
 13. The process of claim 12 wherein the sheet iscooled during steps (3) and (4) at a rate of from about 5° C. to about100° C. per minute.
 14. A process for providing a packaged cosmeticdevice comprising: a pre-formed sheet and a coating compositioncomprising a skin benefit agent; comprising the steps of: (1) providingan unsealed package; (2) applying the coating composition in thepackage; (3) placing the pre-formed sheet made by the process of claim12 in the package; and (4) sealing the package; wherein the steps are incommunication with each other to provide a continuous line process. 15.A use of the pre-formed object made by the process of claim 1 as acosmetic product, a pharmaceutical product, or a food product.
 16. Acosmetic device comprising: (1) a pre-formed sheet comprising: (a) fromabout 10% to about 99.5% water; and (b) from about 0.5% to about 20%polysaccharide gelling agent having a sol-gel transition point betweenabout 25° C. and about 80° C.; wherein the pre-formed sheet is free of asupporting substrate, has a thickness of from about 0.1 mm to about 5mm, and a first surface and a second surface, the first surface having arepeating texture having a depth of from about 10 μm to about 500 μm ata frequency of from about 0.2 to about 1 per mm wherein the depth of thetexture is at least about 10% of the thickness of the pre-formed sheet;and (2) a coating composition comprising a skin benefit agent and havinga viscosity of from about 1000 mPa.s to about 30,000 mPa.s; wherein therepeating texture is so designed to provide a network of channels thatallows fluid communication of the coating composition when the firstsurface is worn on the skin.
 17. The cosmetic device of claim 16wherein: the thickness of the pre-formed sheet is from about 0.5 mm toabout 2.0 mm; the repeating texture has a depth of from about 50 μm toabout 200 μm at a frequency of from about 0.3 to about 0.7 per mm; andthe coating composition has a viscosity of from about 5000 mPa.s toabout 15,000 mPa.s.
 18. The cosmetic device of claim 16 wherein thesecond surface has a repeating texture.